醋酸地塞米松眼用凝胶剂的制备与质量控制

目的: 制备醋酸地塞米松凝胶剂,考察其质量与体外释放的特征.方法: 以醋酸地塞米松为主药,卡波谱为凝胶基质,制备醋酸地塞米松眼用凝胶剂,用紫外分光光度法测定其含量,用透析法考察其体外释放行为.结果: 醋酸地塞米松凝胶剂中醋酸地塞米松的平均含量为标示量的99.51%,RSD1.43%.透析实验考察一周,平均释药百分率为68.26%.结论: 该凝胶剂制备简单,性质稳定,质量可控, 释放时间延长.

Preparation and Quality Control of Dexamethasone Acetate Gel for Ophthalmic Use

Objective: To prepare the dexamethasone acetate gel and investigate its quality and the character of its release in vitro .Method: The gel was prepared with dexamethasone acetate as the main component and carbopol as the base material. The content of dexamethasone acetate in the gel was determined by UV spectropkotometry, and the character of its release in vitro was investigated by dialysis method.Result: The average content of dexamethasone acetate in the gel was 99.51% of the labeled amount with a RSD of 1.43% . The average release in vitro amount within a week was 68% from the gel.Conclusion: The gel can be prepared easily. It is stable and its quality can be easily controlled. The release time is proved to be prolonged.